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| Name | Class |
|---|---|
| BVMed - The German Medical Technology Association | UNKNOWN |
| German Society for Angiology - Society for Vascular Medicine (DGA) | OTHER |
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The PTA-Registry (PTA-REG) is a prospective health services research registry to monitor and follow-up patients with peripheral arterial disease undergoing endovascular peripheral intervention. The PTA-REG has an interdisciplinary approach: cardiologists, angiologists, and radiologists contributed actively to this registry.
The registry was created for the following purposes: evaluation of the clinical effectiveness, safety and quality of the endovascular therapy, and history of the disease after endovascular therapy. The resulting specific research questions were determination of the technical and clinical success of the procedure, monitoring of periinterventional complications, evaluation of vessel patency, amputation rate, mortality, and major adverse cardiac events during the follow-up. In addition, the quality of life after endovascular peripheral intervention over a period of two years was evaluated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTA, balloon angioplasty, stent | Device |
| Measure | Description | Time Frame |
|---|---|---|
| death of any cause | 2 years | |
| revascularization (TLR, TVR) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| minor or major amputation | 2 years | |
| major adverse cardiac events and stroke | 2 years | |
| quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female patients with peripheral arterial disease of the iliac and lower extremity arteries and appropriate clinical indication for treatment with PTA according to current guidelines were included in the registry. Presence of written informed consent for participating in the registry was mandatory. There were no exclusion criteria and no age restriction.
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| ID | Term |
|---|---|
| D014339 | Truncus Arteriosus, Persistent |
| ID | Term |
|---|---|
| D001028 | Aortopulmonary Septal Defect |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
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| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| D015607 | Stents |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
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The follow-up was performed at months 6, 12, 18, and 24. The follow-up consisted of a quality of life questionnaire (EQ-5D)
| 2 years |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014656 |
| Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |